Drug Safety Information for DELATESTRYL (Testosterone enanthate)

Safety-related Labeling Changes for DELATESTRYL (TESTOSTERONE ENANTHATE) Brand name discontinued; available as generic: FDA Link

Adverse Drug Reactions for DELATESTRYL* (Testosterone enanthate)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with DELATESTRYL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Myocardial infarction17
2Atrial fibrillation17
3Pain15
4Anxiety14
5Acute generalised exanthematous pustulosis12
6Drug ineffective12
7Back pain12
8Nausea12
9Diarrhoea11
10Fatigue11
11Deep vein thrombosis9
12Cardiac failure congestive9
13Pyrexia9
14Oedema peripheral9
15Dizziness9
16Headache9
17Depression9
18Dyspnoea8
19Rash8
20Vomiting8

* This side effect also appears in "Top 10 Side Effects of DELATESTRYL " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking DELATESTRYL
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication158
2Blood testosterone decreased112
3Drug abuse57
4Androgen replacement therapy36
5Hypogonadism31
6Hormone replacement therapy19
7Protein anabolism increased12
8Gonadotrophin deficiency11
9Hypogonadism male10
10Muscle mass9

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for DELATESTRYL

Total Reports Filed with FDA: 1084


Number of FDA Adverse Event Reports by Patient Age for DELATESTRYL

Total Reports Filed with FDA: 1084*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Testosterone enanthate (Primoteston depot, Delatestryl)

Charts are based on 1084 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and DELATESTRYL Reviews and Review Summary .

Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.

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